System for treating acute and chronic heart failure

Patent metadata

Field	Value
Publication number	US-2018243541-A1
Application number	US-201615753300-A
Country	US
Kind code	A1
Filing date	Aug 15, 2016
Priority date	Aug 17, 2015
Publication date	Aug 30, 2018
Grant date	—

Abstract

Systems and methods and devices are provided for arresting or reversing the effects of myocardial remodeling and degeneration after cardiac injury, without the potential drawbacks associated with previously existing systems and methods, by at least partially occluding flow through the superior vena cava over multiple cardiac cycles, and more preferably, by adjusting the interval or degree of occlusion responsive to a sensed level of patient activity. In some embodiments, a controller is provided that actuates a drive mechanism responsive to a sensed level of patient activity to provide at least partial occlusion of the patient's superior vena cava, while a data transfer circuit of the controller provides bi-directional transfer of physiologic data to the patient's smartphone or tablet to permit display and review of such data.

First claim

1 . A system for treating heart failure in a patient, the apparatus comprising:
a catheter having a proximal end and a distal region, the catheter configured for placement though a subclavian or jugular vein of a patient so that the distal region is disposed in a superior vena cava of the patient; a flow limiting element disposed on the distal region of the catheter, the flow limiting element configured to be selectively actuated to at least partially occlude the superior vena cava; and a controller configured to be operatively coupled to the catheter to intermittently actuate the flow limiting element to at least partially occlude the superior vena cava over multiple cardiac cycles, the controller including a processor programmed to: apply a stored value corresponding to a predetermined flow limiting interval during which the flow limiting element is to be actuated; receive an input corresponding to a physiologic parameter of the patient indicative of fluctuations in the patient's hemodynamic state; generate an output corresponding to an adjustment of the predetermined flow limiting interval; and apply the output to revise the predetermined flow limiting interval.

2 . The system of claim 1 , wherein the proximal end of the catheter is adapted to extend outside the patient and the controller has a size and weight selected to enable the controller to be worn by the patient.

3 . The system of claim 1 , wherein the controller further comprises a drive mechanism configured to be coupled to the flow limiting element of the catheter.

4 . The system to claim 1 , further comprising a data transfer circuit configured to receive data from a sensor and to provide the input to the processor of the controller.

5 . The system of claim 1 , wherein catheter comprises one or more sensors.

6 . The system of claim 5 , wherein the one or more sensors comprise at least a blood pressure sensor and electrodes for detecting a heart rate of the patient.

7 . The system of claim 4 , wherein the data transfer circuit is configured to wirelessly receive data from a heart rate monitor.

8 . The system of claim 4 , wherein the data transfer circuit is configured to bi-directionally communicate physiologic data to a computing device of the patient for display to the patient.

9 . The system of claim 8 , wherein the controller is programmed to send an alert condition to a clinician monitoring the patient via a cellular communications capability of the computing device.

10 . The system of claim 3 , wherein the flow limiting element is coupled to the drive mechanism via an actuation wire.

11 . The system of claim 3 , wherein the flow limiting element transitions from a collapsed contracted state to an expanded deployed state when actuated by the drive mechanism.

12 . The system of claim 3 , wherein the flow limiting element transitions from a collapsed contracted state to an expanded deployed state when actuated by the drive mechanism, and the flow limiting element is configured to transition to the collapsed contracted state if operatively disconnected from the controller.

13 . The system of claim 1 , wherein the controller is configured for implantation.

14 . The system of claim 1 , further comprising, one or more external power sources in electrical communication with the controller and configured to provide power to the controller.

15 . The system of claim 14 , wherein the one or more external power sources generates an alert when a power level of the one or more external power sources is below a threshold power level.

16 . A system for treating heart failure in a patient, the apparatus comprising:
a catheter having a proximal end and a distal region, the catheter configured for placement though a subclavian or jugular vein of a patient so that the distal region is disposed in a superior vena cava of the patient; a flow limiting element disposed on the distal region of the catheter, the flow limiting element configured to be selectively actuated to at least partially occlude the superior vena cava; and an implantable controller configured to be operatively coupled to the catheter to intermittently actuate the flow limiting element to at least partially occlude the superior vena cava over multiple cardiac cycles, the controller including a processor programmed to: apply a stored value corresponding to a predetermined flow limiting interval during which the flow limiting element is to be actuated; receive an input corresponding to a physiologic parameter indicative of the patient's hemodynamic state; generate an output corresponding to an adjustment of the actuation of the flow limiting element if the input received falls outside a predetermined threshold; and apply the output to revise the actuation of the flow limiting element.

17 . The system of claim 16 , wherein the adjustment of the actuation of the flow limiting element comprises adjustment of the predetermined flow limiting interval such that the output applied revises the predetermined flow limiting interval.

18 . The system of claim 16 , wherein the adjustment of the actuation of the flow limiting element comprises adjustment of a degree of occlusion by the flow limiting element such that the output applied revises the degree of occlusion by the flow limiting element.

19 . The system to claim 16 , further comprising a data transfer circuit configured to receive data from a sensor and to provide the input to the processor of the implantable controller.

20 . The system of claim 16 , wherein the input received corresponds to at least one of heart rate or blood pressure of the patient.

Assignees

• Tufts Medical Ct Inc

Inventors

• Kapur Navin K
• Karas Richard H

Classifications

• A61B5/026

  Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)} · CPC title

• A61B17/12172

  having a pre-set deployed three-dimensional shape (methods of manufacturing A61B2017/00526) · CPC title

• A61B2017/00199

  with a console, e.g. a control panel with a display · CPC title

• A61B2017/00221

  with wireless transmission of data, e.g. by infrared radiation or radiowaves · CPC title

• A61B17/1204

  temporary occlusion · CPC title